Terumo Aortic today announced that the US Food and Drug Administration (FDA) has granted approval of the RelayPro Thoracic Stent-Graft System for sale in the United States for the treatment of patients with thoracic aortic aneurysms (TAA) and penetrating atherosclerotic ulcers (PAUs).
This approval follows the successful completion of the RelayPro aneurysm study in the United States and Japan; this was a prospective, multi-centre, non-blinded, non-randomised study of the RelayPro thoracic stent-graft in 110 patients with thoracic aneurysms and penetrating atherosclerotic ulcers in the descending aorta.
RelayPro is a low profile, next generation thoracic stent-graft device designed to expand the treatment of thoracic endovascular aortic repair (TEVAR) to patients with smaller access vessels. The platform utilises the same stent design, materials and foundational Dual Sheath Technology of the proven RelayPlus system; with a 3 to 4 Fr reduction in outer profile, RelayPro delivers the accuracy, control and confidence of RelayPlus without compromising device integrity and durability. RelayPro is the only lower profile device with a Non-Bare Stent (NBS) design available in the United States to treat aneurysms and penetrating atherosclerotic ulcers. This configuration is further complemented by a Bare Stent version; both designs offer a wide range of sizes to meet the specific anatomical needs of patients.
Co-National Principal Investigator of the aneurysm study, Wilson Y Szeto MD, Chief of Cardiovascular Surgery, Penn Presbyterian University of Pennsylvania Health System, Philadelphia, US, commented: "RelayPro's ability to navigate smoothly over the arch as a result of the Dual Sheath system enables accurate deployment, and combined with the low profile of the device, this allows me to successfully treat complex anatomy with precision."
Furthermore, Co-National Principal Investigator, Venkatesh G Ramaiah MD, Chief of Vascular and Endovascular Surgery, Honor Health Network, Scottsdale, Arizona, US, added: "One of the key features and benefits of RelayPro is being able to choose from a range of sizes and tapers allowing me to tailor my device selection to meet the individual needs of each patient and adapt to complex anatomy and morphology. In addition, the unique delivery system, the low profile and the options of Bare Stent and Non-Bare Stent are clear differentiators. This is a landmark advancement in the endovascular treatment of thoracic aneurysms."
Paul Kuznik, President of Terumo Aortic North America said: "Today's announcement represents a significant opportunity for Terumo Aortic in the United States further complementing our abdominal endovascular and open surgical graft portfolio, as well as expanding our range of products to treat thoracic aortic aneurysms. We are committed to providing physicians with innovative aortic solutions for the treatment of their patients."
RelayPro received CE Mark approval in 2017 and is integral to Terumo Aortic's market leading portfolio of surgical, endovascular and hybrid devices to treat every segment of the aorta.
About Terumo Aortic
At Terumo Aortic, we partner with our customers to revolutionise aortic care. We deliver innovation, versatility and precision with the broadest range of solutions that can be personalised for every patient. We are further complementing our implantable device portfolio through the development of digital technologies.
Terumo (TSE: 4543) is a global leader in medical technology and has been committed to “Contributing to Society through Healthcare” for 100 years. Based in Tokyo and operating globally, Terumo employs more than 30,000 associates worldwide to provide innovative medical solutions in more than 160 countries and regions. The company started as a Japanese thermometer manufacturer, and has been supporting healthcare ever since. Now, its extensive business portfolio ranges from vascular intervention and cardio-surgical solutions, blood transfusion and cell therapy technology, to medical products essential for daily clinical practice such as transfusion systems, diabetes care, and peritoneal dialysis treatments. Terumo will further strive to be of value to patients, medical professionals, and society at large.